Nursing and Pharmacy Care Between Capecitabine and 5-Fluoruracil Regimens

NCT ID: NCT02063412

Last Updated: 2017-02-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-04-30

Brief Summary

The objective of this study is to compare the possible time savings from reduction of nursing and pharmacy time to manage AEGC patients using capecitabine-based regimens versus traditional intravenous chemotherapy in the Hong Kong public hospital setting.

Detailed Description

Advanced esophageal and gastric cancer (AEGC) have ranked in the top 10 cancer-related cause of death worldwide, with approximately one million new cases each year. Over half of new cases are in East Asia. The traditional chemotherapy for AEGC remains on intravenous (IV) fluorouracil (5-FU), cisplatin, and the anthracyclines. Trials favoured the combined use of 5-FU and cisplatin for superior efficacy and quality of life in AEGC patients. Recent years, oral chemotherapy has a more practical and economic advantages over IV regimen. It is understandable that patients prefer oral regimens as long as the clinical efficacy is maintained. Oral treatment strategy preserves quality of life for AEGC patients. In addition, it may also have additional cost saving in the nursing and pharmacy time. It is because a significant amount of time can be saved in both nursing and pharmacy for the preparation and administration of IV chemotherapy However, there is a lack of local data to demonstrate the impact of pharmacy and nursing care utilizing capecitabine-based regimen comparing to traditional IV chemotherapy in MCRC patients of Hong Kong.

Conditions

Gastric Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

XELOX

Capecitabine (Xeloda) 1000mg/m2 po bid x 14 days Oxaliplatin (Eloxatin) 130mg/m2 iv over 2 hrs d1 Q3w x 8 cycles

No interventions assigned to this group

XP

Cisplatin (CDDP) 80 mg/m2 iv over 3 hrs d1 Capecitabine (Xeloda) 1000 mg/m2 po bid d1-14, Q3w

No interventions assigned to this group

FOLFOX

Leucovorin 200 mg/m2 iv over 2 hrs before 5-FU, d1 and d2 5-FU 400mg/m2 iv bolus and then 600 mg/m2 iv over 22 hrs, d1 and d2 Q2w

No interventions assigned to this group

FP

Cisplatin (CDDP) 100 mg/m2 iv d1 5-FU 1000 mg/m2/d civi d1-5, Q4w

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Aged 18 or above

2. Diagnosed with AEGC and were prescribed with either XELOX-based or FOLFOX4- based chemotherapy treatment

Exclusion Criteria

1. Persons < 18 years of age;

2. Pregnant or lactating women;

3. Persons related unequally to investigators (e.g. student, employee);

4. Special population (e.g. prisoner, mentally, congnitively disabled);

5. Patients who refused to sign consent or not willing to participate.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Queen Elizabeth Hospital, Hong Kong

OTHER

Sponsor Role: collaborator

Princess Margaret Hospital, Hong Kong

OTHER_GOV

Sponsor Role: collaborator

Vivian Wing Yan Lee

OTHER

Sponsor Role: lead

Responsible Party

Vivian Wing Yan Lee

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vivian WY Lee, PharmD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Other Identifiers

TR116583VLKZ003

Identifier Type: OTHER

Identifier Source: secondary_id

Roche-TR116583

Identifier Type: -

Identifier Source: org_study_id